510(k) K031931

ECHO SOUNDER EX-101EX 8 MHZ by Koven Technology, Inc. — Product Code DPW

K031931 is an FDA 510(k) premarket notification submitted by Koven Technology, Inc. for the device "ECHO SOUNDER EX-101EX 8 MHZ". The FDA issued a decision of Substantially Equivalent on February 13, 2004. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Koven Technology, Inc. has at least 10 other 510(k) clearances on record.